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Transcatheter Heart Valve
The PARTNER Trial
The PARTNER II Trial
Transcatheter Aortic Valve Replacement
Edwards Lifesciences is sponsoring a clinical trial in the U.S. to study the safety and effectiveness of the investigational device Edwards SAPIEN 3 transcatheter heart valve and associated delivery systems.
Transcatheter Aortic Valve Replacement (TAVR)
TAVR is a less invasive procedure that does not require open-heart surgery to replace the aortic valve and is for patients who have been diagnosed with severe symptomatic calcified native aortic valve stenosis.
The PARTNER II Trial:
Currently enrolling for the SAPIEN 3 Cohort
The SAPIEN 3 cohort of The PARTNER II Trial is evaluating the TAVR procedure in patients with severe symptomatic calcified native aortic valve stenosis, and who are considered to be at intermediate risk for open-heart surgery. The SAPIEN 3 cohort is a historical-controlled study comparing the third generation transcatheter heart valve therapy (Edwards SAPIEN 3 valve) against the second generation (Edwards SAPIEN XT valve).
* Intermediate risk as defined as 4-8%
** Decision based on physician assessment
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use. This product has not been approved for marketing in the United States, and is not available for commercial sale in the United States.
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